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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  osimertinib
Trade Name:  Tagrisso
Date Designated:  09/04/2014
Orphan Designation:  Treatment of epidermal growth factor receptor mutation-positive non-small cell lung cancer
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  11/13/2015 
Approved Labeled Indication:  For treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR TKI therapy
Exclusivity End Date:    11/13/2022 
Exclusivity Protected Indication* :  For treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR TKI therapy
AstraZeneca Pharmaceuticals LP
P. O. Box 8355
1800 Concord Pike
Wilmington, Delaware 19803
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
 
Generic Name:  osimertinib
Trade Name:  Tagrisso
Date Designated:  09/04/2014
Orphan Designation:  Treatment of epidermal growth factor receptor mutation-positive non-small cell lung cancer
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  04/18/2018 
Approved Labeled Indication:  TAGRISSO® is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
Exclusivity End Date:    04/18/2025 
Exclusivity Protected Indication* :  TAGRISSO® is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
AstraZeneca Pharmaceuticals LP
P. O. Box 8355
1800 Concord Pike
Wilmington, Delaware 19803
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
 
Generic Name:  osimertinib
Trade Name:  Tagrisso
Date Designated:  09/04/2014
Orphan Designation:  Treatment of epidermal growth factor receptor mutation-positive non-small cell lung cancer
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  12/18/2020 
Approved Labeled Indication:  adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
Exclusivity End Date:    12/18/2027 
Exclusivity Protected Indication* :  adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
AstraZeneca Pharmaceuticals LP
P. O. Box 8355
1800 Concord Pike
Wilmington, Delaware 19803
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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